This open-label pilot study (n=5) aims to investigate whether a two-part outpatient procedure, utilising a modified ketogenic diet followed by a series of titrated ketamine infusions, can lead to improvements or remission of chronic anorexia nervosa in adults who have experienced symptoms for at least three years despite undergoing treatment involving at least two different modalities.
The study, sponsored by Homeostasis Therapeutics, LLC, is conducted in South Windsor, Connecticut, United States, and led by Principal Investigator Lori Calabrese, MD from Innovative Psychiatry. The study started on April 12, 2021, and concluded on July 26, 2022, with an enrollment of 5 participants.
Participants undergo a two-day immersive educational program to initiate the modified ketogenic diet, followed by a four-week period of adopting the diet at home, with regular follow-up. This is followed by a series of titrated intravenous ketamine infusions scheduled over two weeks. Throughout the study, various objective and psychological measures assess safety and response, with participants being monitored for 12 months.
Trial Details
Trial Number
Sponsors & Collaborators
Homeostasis TherapeuticsHomeostasis Therapeutics is a pioneering company dedicated to revolutionizing the treatment of anorexia nervosa.